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New combo therapy aims to shrink head and neck tumors before surgery

NCT ID NCT07554768

Disease control Sponsor: Chen Chunyan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving radiation along with immunotherapy before surgery works better than immunotherapy alone for people with advanced head and neck cancer. About 36 adults with treatable but advanced cancer will be split into two groups. The goal is to see if the combination leads to fewer cancer cells left after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically confirmed, treatment-naive, resectable head and neck squamous cell carcinoma (HNSCC). 2. Clinical stage III to IVB (according to AJCC 8th edition), excluding HPV-positive oropharyngeal cancer. 3. PD-L1 expression with a Combined Positive Score (CPS) ≥ 1. 4. Karnofsky Performance Status (KPS) score ≥ 70. 5. Age between 18 and 70 years (inclusive). 6. Evaluated by a multidisciplinary team (MDT) as resectable or borderline resectable, and suitable for preoperative Stereotactic Body Radiotherapy (SBRT). 7. Adequate organ function within 7 days prior to enrollment, meeting laboratory criteria for hematology, liver, and renal function. 8. Anatomical requirements for SBRT: Lesions must be localized with adequate anatomical space for high-precision radiotherapy without exceeding safety limits for Organs at Risk (OARs). 9. Voluntary participation with a signed Informed Consent Form (ICF). Exclusion Criteria: 1. Prior radical surgery, radiotherapy, or immunotherapy for head and neck malignancies. 2. Severe comorbidities that may interfere with study participation, such as uncontrolled cardiovascular disease or active infections. 3. Active Hepatitis B virus (HBV) infection (HBsAg positive and HBV DNA ≥ 500 IU/mL). 4. Pregnant or breastfeeding women. 5. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for enrollment.

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma Squamous Cell Carcinoma of Head and Neck

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck squamous cell carcinoma Locally advanced head and neck squamous cell carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.